Baloxavir marboxil (Xofluza) was approved to help patients in the early stages of influenza infection. However, as the reinvigorated COVID-19 pandemic now coincides with flu season, the Food and Drug Administration has approved it as a preventive measure for patients who have simply been exposed to influenza. As with the original indication, it is approved for patients 12 years of age and older. In a statement accompanying the FDA announcement, Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, acknowledged that this flu season “is anticipated to be unlike any other because it will coincide with the coronavirus pandemic” and urged patients and providers alike to step up efforts to reduce risk for influenza infection. The new approval was preceded by one randomized, double-blind, controlled trial in which 607 subjects age 12 years and older were exposed to a person with influenza in their household, then given either a single dose of Xofluza or a single dose of a placebo. One percent of the patients who received Xofluza presented with fever and at least one respiratory symptoms between 1 and 10 days after exposure, compared with 13% who received a placebo.
Be Aware: Hoping to Head Off a Twindemic, FDA Has Approved a ‘New’ Drug to Prevent Flu